The following data is part of a premarket notification filed by Gpc Medical Limited with the FDA for Gpc Intraheal Intramedullary Nailing System.
| Device ID | K203811 |
| 510k Number | K203811 |
| Device Name: | GPC Intraheal Intramedullary Nailing System |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | GPC Medical Limited GPC Square, M-Block, DDA LSC, Vikas Puri, New Delhi New Delhi, IN 110018 |
| Contact | Vikas Narang |
| Correspondent | Vikas Narang GPC Medical Limited GPC Square, M-Block, DDA LSC, Vikas Puri, New Delhi New Delhi, IN 110018 |
| Product Code | HSB |
| Subsequent Product Code | HTY |
| Subsequent Product Code | HWC |
| Subsequent Product Code | JDS |
| Subsequent Product Code | JDW |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-12-28 |
| Decision Date | 2022-02-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08905892004582 | K203811 | 000 |
| 08905892004681 | K203811 | 000 |
| 08905892004674 | K203811 | 000 |
| 08905892004667 | K203811 | 000 |
| 08905892004650 | K203811 | 000 |
| 08905892004643 | K203811 | 000 |
| 08905892004636 | K203811 | 000 |
| 08905892004629 | K203811 | 000 |
| 08905892004612 | K203811 | 000 |
| 08905892004605 | K203811 | 000 |
| 08905892004698 | K203811 | 000 |
| 08905892004704 | K203811 | 000 |
| 08905892004711 | K203811 | 000 |
| 08905892004575 | K203811 | 000 |
| 08905892004568 | K203811 | 000 |
| 08905892004780 | K203811 | 000 |
| 08905892004773 | K203811 | 000 |
| 08905892004766 | K203811 | 000 |
| 08905892004759 | K203811 | 000 |
| 08905892004742 | K203811 | 000 |
| 08905892004735 | K203811 | 000 |
| 08905892004728 | K203811 | 000 |
| 08905892004599 | K203811 | 000 |